Durvalumab +/− Lenalidomide for T-Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This randomized phase I/II trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma.
Research Team
Christiane Querfeld, MD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for patients with relapsed or refractory cutaneous or peripheral T cell lymphoma. Eligible participants must have confirmed mycosis fungoides (MF) or Sezary syndrome (SS), measurable disease, and adequate organ function. They should not have had certain treatments recently and must be willing to use birth control. Exclusions include prior stem cell transplantation, active infections like HIV, unstable heart disease, severe allergies to similar drugs, and other conditions that could affect safety.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive durvalumab with or without lenalidomide. Treatment repeats every 28 days for up to 13 courses.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- Lenalidomide
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator